- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424729
Minimal-flow Anesthesia and Cognitive Outcomes in Elderly Surgical Patients
Minimal-flow Anesthesia, Surgical Duration, and Postoperative Cognitive Dysfunction in Older Patients
Purpose:
Postoperative cognitive dysfunction (POCD) is a common complication in elderly patients following major surgery and is associated with impaired attention, memory, and executive functions. Advanced age and prolonged surgical duration are among the most important risk factors. Minimal flow anesthesia has been suggested to reduce postoperative cognitive impairment by providing more stable anesthetic depth and reducing physiological stress.
The aim of this study is to investigate the relationship between surgical duration and postoperative cognitive dysfunction in elderly patients undergoing surgery under minimal flow anesthesia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detailed Description:
Postoperative cognitive dysfunction (POCD) is a syndrome characterized by deterioration in cognitive domains such as attention, memory, executive function, and psychomotor speed, particularly in elderly patients after major surgical procedures. POCD may become evident in the early postoperative hours or may present days to weeks after surgery. Its incidence increases with age, prolonged surgical duration, anesthetic technique, comorbid conditions, and perioperative physiological disturbances.
Diagnosis of POCD requires comparison of preoperative baseline cognitive status with postoperative neurocognitive assessments. The Mini-Mental State Examination (MMSE) and the Richmond Agitation-Sedation Scale (RASS) are validated and reliable tools for evaluating cognitive status in the perioperative period.
Minimal flow anesthesia is defined as the use of fresh gas flow rates between 0.25 and 0.5 L/min, allowing partial rebreathing of anesthetic agents. This technique reduces anesthetic consumption, maintains stable anesthetic depth, and preserves temperature and humidity, potentially minimizing physiological stress. Previous studies suggest that minimal flow anesthesia with sevoflurane may be associated with a lower incidence of early postoperative cognitive impairment compared to higher flow techniques.
In this prospective interventional study, patients aged 65-85 years undergoing surgery under minimal flow inhalational anesthesia will be enrolled. Patients will be divided into two groups based on surgical duration: surgeries lasting less than 2 hours and surgeries lasting 2 hours or longer, with 45 patients in each group.
All patients will undergo preoperative cognitive assessment using the MMSE. Standard ASA monitoring and bispectral index (BIS) monitoring will be applied intraoperatively to maintain anesthetic depth between BIS values of 40 and 60. Anesthesia induction and maintenance will be performed using routine anesthetic agents and minimal flow inhalational anesthesia as part of standard clinical practice.
Neuromuscular blockade will be reversed with sugammadex at the end of surgery. Postoperatively, patients will be evaluated using the RASS at the 10th, 30th, and 60th minutes in the recovery room. Neurology consultation will be requested for patients with RASS scores outside the normal range. Vital signs, pain scores (VAS), and blood glucose levels will be recorded during these assessments.
Postoperative cognitive function will be reassessed using the MMSE at 24 hours and on postoperative day 7. Preoperative and postoperative cognitive assessments will be conducted by study investigators who are blinded to surgical duration. The anesthetic management will be performed by anesthesiologists not involved in the study.
The primary objective of this study is to evaluate the association between surgical duration and postoperative cognitive dysfunction in elderly patients undergoing surgery under minimal flow anesthesia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara
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Yenimahalle, Ankara, Turkey (Türkiye), 06170
- Ankara Etlik City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Inclusion Criteria:
- Patients aged between 65 and 85 years
- ASA physical status I-III
- Scheduled for elective surgery under general anesthesia in general surgery or otorhinolaryngology operating rooms
- Planned to receive minimal flow general anesthesia
- Preoperative Mini-Mental State Examination performed
- Able to provide informed consent
Exclusion Criteria:
- Age outside the specified range
- ASA physical status IV or higher
- Severe comorbid disease affecting perioperative stability
- Surgery performed under regional anesthesia
- History of alcohol, drug, or substance abuse
- Significant visual or hearing impairment interfering with cognitive testing
- Refusal to participate
- Known neurological or psychiatric disorders
- Preoperative MMSE score below 24
- Perioperative hemodynamic instability
- Illiteracy preventing completion of cognitive tests
- Postoperative admission to intensive care unit
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: Surgery duration <2 hours
Elderly patients undergoing surgery under minimal flow anesthesia with a surgical duration of less than 2 hours.
Cognitive function will be assessed preoperatively and postoperatively using the Mini-Mental State Examination.
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Cognitive function will be assessed using the Mini-Mental State Examination preoperatively and at postoperative time points.
Other Names:
|
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Experimental: Arm 2: Surgery duration ≥2 hours
Elderly patients undergoing surgery under minimal flow anesthesia with a surgical duration of 2 hours or longer.
Cognitive function will be assessed preoperatively and postoperatively using the Mini-Mental State Examination.
|
Cognitive function will be assessed using the Mini-Mental State Examination preoperatively and at postoperative time points.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mini-Mental State Examination score
Time Frame: Preoperative baseline, postoperative 24 hours, and postoperative day 7
|
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a 30-point scale ranging from 0 to 30, where higher scores indicate better cognitive function. The primary outcome is the change in MMSE score between the preoperative assessment and postoperative assessments. Change in cognitive function assessed by the difference between preoperative and postoperative Mini-Mental State Examination scores. |
Preoperative baseline, postoperative 24 hours, and postoperative day 7
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative cognitive dysfunction
Time Frame: Postoperative 24 hours and postoperative day 7
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The proportion of patients who develop postoperative cognitive dysfunction based on changes in Mini-Mental State Examination (MMSE) scores.
Postoperative cognitive dysfunction will be defined according to a predefined decline in MMSE score compared with the preoperative baseline assessment.
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Postoperative 24 hours and postoperative day 7
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: oya çimen, MD, Ankara Etlik City Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Pathological Conditions, Signs and Symptoms
- Postoperative Cognitive Complications
- Behavioral Disciplines and Activities
- Psychological Tests
- Neuropsychological Tests
- Mental Status and Dementia Tests
Other Study ID Numbers
- AEŞH-EK-2025-187
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Study Protocol
Information comments: The study protocol and individual participant data will not be publicly available. No data sharing is planned for this study and no access to datasets or documents will be provided.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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